- Device
- TRUPULSE™ Generator
- Applicant
- Biosense Webster, Inc.
- PMA number
- P240006
- Supplement
- S012
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2025-12-23
- Decision code
- APPR
- Date received
- 2025-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a software update to the TRUPULSE™ Generator and an update to the user manual of the nGEN™ Pump to facilitate automatic delivery of irrigation at 30 mL/min upon initiation of energy delivery